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Trial record 83 of 161 for:    colon cancer AND Capecitabine AND Fluorouracil

Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363843
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : July 16, 2014
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
William Sikov MD, Brown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colon Cancer
Rectal Cancer
Interventions Drug: FOLFOX6
Radiation: RT with concurrent chemotherapy
Procedure: Surgery
Enrollment 39
Recruitment Details 39 patients we enrolled, 36 completed all 8 cycles of induction modified FOLFOX6, 35 patients completed chemo-radiation, 38 patients underwent surgery.
Pre-assignment Details  
Arm/Group Title Study Arm Only
Hide Arm/Group Description

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
  2. Capecitabine 825 mg/m2 PO BID

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine
Period Title: Overall Study
Started 39
Completed 38 [1]
Not Completed 1
[1]
39 enrolled, 36 completed 8 cycles of mFOLFOX6, 35 completed chemo-radiation, 38 underwent surgery.
Arm/Group Title Study Arm
Hide Arm/Group Description

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
  2. Capecitabine 825 mg/m2 PO BID

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
61
(30 to 79)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  66.7%
>=65 years
13
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
13
  33.3%
Male
26
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Incidence of Complete Resection
Hide Description The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine
Time Frame approx 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm Only
Hide Arm/Group Description:

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
  2. Capecitabine 825 mg/m2 PO BID

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
13
2.Secondary Outcome
Title Evaluate the Toxicity of Study Therapy
Hide Description

Evaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation. Results show number of patients who experienced a SAE. This does not mean all SAEs were deemed related to treatment.

•Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed

Time Frame approx 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Arm Only
Hide Arm/Group Description:

Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine
Overall Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
13
  33.3%
Time Frame From signing consent to post completion of induction (approximately 4 months)
Adverse Event Reporting Description induction AEs and SAEs included for reporting
 
Arm/Group Title Study Arm Only
Hide Arm/Group Description

Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine
All-Cause Mortality
Study Arm Only
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Arm Only
Affected / at Risk (%) # Events
Total   13/39 (33.33%)    
Investigations   
anorexia   1/39 (2.56%)  1
angioderma/allergy   1/39 (2.56%)  1
constipation   1/39 (2.56%)  1
dehydration   1/39 (2.56%)  1
diarrhea   2/39 (5.13%)  2
DVT   1/39 (2.56%)  1
edema   1/39 (2.56%)  1
fever   3/39 (7.69%)  3
gastritis   1/39 (2.56%)  1
LFTs   1/39 (2.56%)  1
migrane/headache   2/39 (5.13%)  2
nausea   3/39 (7.69%)  3
neutropenia   1/39 (2.56%)  1
numbness   1/39 (2.56%)  1
pain-abdominal and cramps   2/39 (5.13%)  2
pain-neck   1/39 (2.56%)  1
Panic Attack   1/39 (2.56%)  1
parasthesia   1/39 (2.56%)  1
rash   1/39 (2.56%)  1
renal failure   1/39 (2.56%)  1
tingling   1/39 (2.56%)  1
thrombocytopenia   1/39 (2.56%)  1
thrombus formation   1/39 (2.56%)  1
TIA   1/39 (2.56%)  1
URI   1/39 (2.56%)  1
UTI   1/39 (2.56%)  1
vomiting   2/39 (5.13%)  2
weakness   1/39 (2.56%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Arm Only
Affected / at Risk (%) # Events
Total   39/39 (100.00%)    
Investigations   
Alk phos   4/39 (10.26%)  4
Albumin   6/39 (15.38%)  6
alopecia   5/39 (12.82%)  5
anemia   21/39 (53.85%)  21
anorexia   6/39 (15.38%)  6
anxiety   4/39 (10.26%)  4
vision disturbances   4/39 (10.26%)  4
pain-bone   3/39 (7.69%)  3
ca   2/39 (5.13%)  2
chills   3/39 (7.69%)  3
cold sensitivity   11/39 (28.21%)  11
constipation   21/39 (53.85%)  21
cough   3/39 (7.69%)  3
creatinine   2/39 (5.13%)  2
dehydration   3/39 (7.69%)  3
diarrhea   16/39 (41.03%)  16
dizziness   6/39 (15.38%)  6
dry skin, acne, itchiness, pruritus   5/39 (12.82%)  5
dyspnea/SOB   5/39 (12.82%)  5
dysuria   2/39 (5.13%)  2
edema   3/39 (7.69%)  3
fatigue   31/39 (79.49%)  31
heartburn   2/39 (5.13%)  2
bili   2/39 (5.13%)  2
glucose   3/39 (7.69%)  3
potassium   9/39 (23.08%)  9
Mg   5/39 (12.82%)  5
Hypersensitivity rxn   4/39 (10.26%)  4
hypertension/tach/palp   5/39 (12.82%)  5
HTN   3/39 (7.69%)  3
infection - general (tooth included here)   2/39 (5.13%)  2
insomnia   4/39 (10.26%)  4
LFTs   10/39 (25.64%)  10
light headedness   2/39 (5.13%)  2
mood alteration   4/39 (10.26%)  4
mucositis/oral thrush   2/39 (5.13%)  2
M/A   2/39 (5.13%)  2
nausea   25/39 (64.10%)  25
neuropathy   19/39 (48.72%)  19
neutropenia   12/39 (30.77%)  12
pain - mouth   5/39 (12.82%)  5
pain-abdominal and cramps   7/39 (17.95%)  7
pain-general   3/39 (7.69%)  3
pain-rectal   7/39 (17.95%)  7
palpatations/ tachycardia   2/39 (5.13%)  2
proteinuria   2/39 (5.13%)  2
rash   5/39 (12.82%)  5
rectal bleeding   3/39 (7.69%)  3
taste alteration   5/39 (12.82%)  5
thrombocytopenia   18/39 (46.15%)  18
uric acid   2/39 (5.13%)  2
urinary frequency   3/39 (7.69%)  3
vomiting   8/39 (20.51%)  8
WBC   4/39 (10.26%)  4
weight loss   5/39 (12.82%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Sikov, MD and Kimberly Perez, MD
Organization: BrUOG
Phone: 4018633000
EMail: kayla_rosati@brown.edu
Layout table for additonal information
Responsible Party: William Sikov MD, Brown University
ClinicalTrials.gov Identifier: NCT01363843     History of Changes
Other Study ID Numbers: BrUOG 224
First Submitted: May 26, 2011
First Posted: June 2, 2011
Results First Submitted: June 17, 2014
Results First Posted: July 16, 2014
Last Update Posted: April 2, 2019